U.S. patent number 11,234,722 [Application Number 15/669,651] was granted by the patent office on 2022-02-01 for devices, systems, and methods to generate a bypass lumen in connection with a chronic total occlusion procedure.
The grantee listed for this patent is Ghassan S. Kassab. Invention is credited to Ghassan S. Kassab.
United States Patent |
11,234,722 |
Kassab |
February 1, 2022 |
Devices, systems, and methods to generate a bypass lumen in
connection with a chronic total occlusion procedure
Abstract
Devices, systems, and methods to generate a bypass lumen in
connection with a chronic total occlusion procedure. An exemplary
method comprises introducing at least part of a first elongated
body into a lumen of an artery so that a distal tip of the first
elongated body is positioned on a first side of an occlusion within
the lumen of the artery; inserting the distal tip of the first
elongated body into a wall of the artery in between a tunica media
and a tunica intima of the artery; advancing the distal tip of the
first elongated body in between the tunica media and the tunica
intima; and further advancing the distal tip of the first elongated
body back into the lumen of the artery to generate a bypass lumen
and so that the distal tip is positioned on an opposite second side
of the occlusion within the lumen.
Inventors: |
Kassab; Ghassan S. (La Jolla,
CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Kassab; Ghassan S. |
La Jolla |
CA |
US |
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Family
ID: |
61071600 |
Appl.
No.: |
15/669,651 |
Filed: |
August 4, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180036021 A1 |
Feb 8, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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62370753 |
Aug 4, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/3417 (20130101); A61B 17/3478 (20130101); A61B
17/22 (20130101); A61B 2017/00252 (20130101); A61B
2017/00026 (20130101); A61B 2017/22095 (20130101); A61B
2017/22061 (20130101); A61B 2017/320048 (20130101); A61B
2017/00876 (20130101) |
Current International
Class: |
A61B
17/22 (20060101); A61B 17/34 (20060101); A61B
17/00 (20060101); A61B 17/32 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Jamialahmadi; Majid
Attorney, Agent or Firm: 3DT Holdings, LLC
Parent Case Text
PRIORITY
The present application is related to, and claims the priority
benefit of, U.S. Provisional Patent Application Ser. No.
62/370,753, filed Aug. 4, 2017, the contents of which are hereby
incorporated into the present disclosure directly and by reference
in their entirety.
Claims
The invention claimed is:
1. A method, comprising the steps of: introducing at least part of
a first elongated body into a lumen of an artery so that a distal
tip of the first elongated body is positioned on a first side of an
occlusion within the lumen of the artery, wherein the distal tip of
the first elongated body comprises an impedance detector, the
impedance detector configured to measure first impedance data of
the lumen and second impedance data of a wall of the artery,
wherein the first impedance data is different from the second
impedance data; inserting the distal tip of the first elongated
body into the wall of the artery in between a tunica media and a
tunica intima of the artery; identifying a change in impedance
between contacting the tunica intima and contacting the tunica
media; advancing the distal tip of the first elongated body in
between the tunica media and the tunica intima; and further
advancing the distal tip of the first elongated body back into the
lumen of the artery to generate a bypass lumen and so that the
distal tip is positioned on an opposite second side of the
occlusion within the lumen of the artery, wherein the distal tip of
the first elongated body remains between the tunica media and the
tunica intima until the distal tip of the first elongated body is
advanced back into the lumen of the artery so that the distal tip
is positioned on the opposite second side of the occlusion within
the lumen of the artery.
2. The method of claim 1, further comprising the steps of:
advancing a balloon catheter over at least part of the first
elongated body so that a balloon of the balloon catheter is
positioned within the bypass lumen between the tunica media and the
tunica intima of the artery adjacent to the occlusion; and
inflating the balloon within the bypass lumen so to expand the
bypass lumen.
3. The method of claim 2, further comprising the steps of:
deflating the balloon; and removing the balloon catheter and the at
least part of the first elongated body from the artery to allow
blood present within the lumen of the artery to flow through the
bypass lumen.
4. The method of claim 3, performed to and sufficient to treat a
chronic total occlusion (CTO) condition.
5. The method of claim 1, further comprising the step of:
introducing at least part of a second elongated body into the lumen
of the artery so that a distal tip of the second elongated body is
positioned on the opposite second side of the occlusion within the
lumen of the artery; wherein the step of further advancing is
performed to further advance the distal tip of the first elongated
body so that it contacts the distal tip of the second elongated
body.
6. The method of claim 5, wherein the distal tip of the first
elongated body is magnetically attracted to the distal tip of the
second elongated body.
7. A method, comprising the steps of: introducing at least part of
a first elongated body into a lumen of an artery so that a distal
tip of the first elongated body is positioned on a first side of an
occlusion within the lumen of the artery, wherein the distal tip of
the first elongated body comprises an impedance detector, the
impedance detector configured to measure first impedance data of
the lumen and second impedance data of a wall of the artery,
wherein the first impedance data is different from the second
impedance data; inserting the distal tip of the first elongated
body into the wall of the artery in between a tunica media and a
tunica intima of the artery; identifying a change in impedance
between contacting the tunica intima and contacting the tunica
media; advancing the distal tip of the first elongated body in
between the tunica media and the tunica intima; further advancing
the distal tip of the first elongated body back into the lumen of
the artery to generate a bypass lumen and so that the distal tip is
positioned on an opposite second side of the occlusion within the
lumen of the artery, wherein the distal tip of the first elongated
body remains between the tunica media and the tunica intima until
the distal tip of the first elongated body is advanced back into
the lumen of the artery so that the distal tip is positioned on the
opposite second side of the occlusion within the lumen of the
artery; advancing a balloon catheter over at least part of the
first elongated body so that a balloon of the balloon catheter is
positioned within the bypass lumen between the tunica media and the
tunica intima of the artery adjacent to the occlusion; inflating
the balloon within the bypass lumen so to expand the bypass lumen;
deflating the balloon; and removing the balloon catheter from the
artery to allow blood present within the lumen of the artery to
flow through the bypass lumen.
8. The method of claim 7, further comprising the step of:
introducing at least part of a second elongated body into the lumen
of the artery so that a distal tip of the second elongated body is
positioned on the opposite second side of the occlusion within the
lumen of the artery; wherein the step of further advancing is
performed to further advance the distal tip of the first elongated
body so that it contacts the distal tip of the second elongated
body.
9. The method of claim 8, wherein the distal tip of the first
elongated body is magnetically attracted to the distal tip of the
second elongated body.
10. The method of claim 7, performed to and sufficient to treat a
chronic total occlusion (CTO) condition.
Description
INCORPORATION BY REFERENCE
U.S. patent application Ser. No. 14/215,012 of Kassab, filed Mar.
16, 2014 and issued as U.S. Pat. No. 9,462,960 on Oct. 11, 2016, is
hereby incorporated by reference herein in its entirety.
BACKGROUND
Chronic Total Occlusions (CTOs) exist when a vessel, such as an
artery, is completely blocked, due to calcification, thrombus, or
other blockage. Traditional balloon angioplasty procedures can
therefore not be performed because, for example, a wire cannot
successfully pierce the blockage to permit a balloon catheter to
operate therethrough
During CTO treatment procedures, the treating
physicians/interventionalists frequently need to enter the
sub-intimal space using some sort of device as the lumens of the
vessels at issue are completely blocked. The general problem is
that the physicians do not know whether the devices they are using
are in the lumen of the vessel or in the sub-intimal space of the
vessel.
Current CTO treatment can involve the use of two devices, namely a
first device antegrade to the CTO and a second device retrograde to
the CTO, whereby the two devices are effectively connected to one
another by ballooning the intima. Such a procedure also requires
both devices to either have their distal ends within the lumen at
the same time or in the subintimal space at the same time for the
procedure to work. Furthermore, the physician would need to know
whether the tips of the two devices physically touch one another.
Said treatment procedure is not only difficult to perform, but
includes several guesses as to where the distal portions of the two
devices are relative to one another, calling into question the
effectiveness and potential safety of such a procedure.
In view of the same, methods to treat CTOs and devices and systems
useful to perform the same would be well appreciated in the
marketplace.
BRIEF SUMMARY
The present disclosure includes disclosure of a method, comprising
the steps of introducing at least part of a first elongated body
into a lumen of an artery so that a distal tip of the first
elongated body is positioned on a first side of an occlusion within
the lumen of the artery; inserting the distal tip of the first
elongated body into a wall of the artery in between a tunica media
and a tunica intima of the artery; advancing the distal tip of the
first elongated body in between the tunica media and the tunica
intima; and further advancing the distal tip of the first elongated
body back into the lumen of the artery to generate a bypass lumen
and so that the distal tip is positioned on an opposite second side
of the occlusion within the lumen of the artery. The present
disclosure includes disclosure of a method, further comprising the
steps of advancing a balloon catheter over at least part of the
first elongated body so that a balloon of the balloon catheter is
positioned within the bypass lumen between the tunica media and the
tunica intima of the artery adjacent to the occlusion; and
inflating the balloon within the bypass lumen so to expand the
bypass lumen. The present disclosure includes disclosure of a
method, further comprising the steps of deflating the balloon; and
removing the balloon catheter and the at least part of the first
elongated body from the artery to allow blood present within the
lumen of the artery to flow through the bypass lumen.
The present disclosure includes disclosure of a method, further
comprising the step of introducing at least part of a second
elongated body into the lumen of the artery so that a distal tip of
the second elongated body is positioned on the opposite second side
of the occlusion within the lumen of the artery; wherein the step
of further advancing is performed to further advance the distal tip
of the first elongated body so that it contacts the distal tip of
the second elongated body. The present disclosure includes
disclosure of a method, wherein the distal tip of the first
elongated body is magnetically attracted to the distal tip of the
second elongated body. The present disclosure includes disclosure
of a method, wherein the first elongated body comprises an
impedance detector, the impedance detector configured to obtain
first impedance data within the lumen and second impedance data
within the wall of the artery, wherein the first impedance data is
different from the second impedance data. The present disclosure
includes disclosure of a method, performed to and sufficient to
treat a chronic total occlusion (CTO) condition.
The present disclosure includes disclosure of a method, comprising
the steps of introducing at least part of a first elongated body
into a lumen of an artery so that a distal tip of the first
elongated body is positioned on a first side of an occlusion within
the lumen of the artery; inserting the distal tip of the first
elongated body into a wall of the artery in between a tunica media
and a tunica intima of the artery; advancing the distal tip of the
first elongated body in between the tunica media and the tunica
intima; further advancing the distal tip of the first elongated
body back into the lumen of the artery to generate a bypass lumen
and so that the distal tip is positioned on an opposite second side
of the occlusion within the lumen of the artery; advancing a
balloon catheter over at least part of the first elongated body so
that a balloon of the balloon catheter is positioned within the
bypass lumen between the tunica media and the tunica intima of the
artery adjacent to the occlusion; inflating the balloon within the
bypass lumen so to expand the bypass lumen; deflating the balloon;
and removing the balloon catheter from the artery to allow blood
present within the lumen of the artery to flow through the bypass
lumen.
The present disclosure includes disclosure of a method, further
comprising the step of introducing at least part of a second
elongated body into the lumen of the artery so that a distal tip of
the second elongated body is positioned on the opposite second side
of the occlusion within the lumen of the artery; wherein the step
of further advancing is performed to further advance the distal tip
of the first elongated body so that it contacts the distal tip of
the second elongated body. The present disclosure includes
disclosure of a method, wherein the distal tip of the first
elongated body is magnetically attracted to the distal tip of the
second elongated body. The present disclosure includes disclosure
of a method, wherein the first elongated body comprises an
impedance detector, the impedance detector configured to obtain
first impedance data within the lumen and second impedance data
within the wall of the artery, wherein the first impedance data is
different from the second impedance data. The present disclosure
includes disclosure of a method, performed to and sufficient to
treat a chronic total occlusion (CTO) condition.
The present disclosure includes disclosure of a device, comprising
a first elongated body and a first element positioned at or near
the distal end of the first elongated body; wherein the device is
configured to be introduced, at least partially, into a lumen of an
artery so that a distal tip of the first elongated body is
positioned on a first side of an occlusion within the lumen of the
artery, whereby the distal tip can be inserted into a wall of the
artery in between a tunica media and a tunica intima of the artery,
whereby the distal tip can be advanced in between the tunica media
and the tunica intima, and whereby the distal tip can be further
advanced back into the lumen of the artery to generate a bypass
lumen and so that the distal tip is positioned on an opposite
second side of the occlusion within the lumen of the artery. The
present disclosure includes disclosure of a device, wherein the
first element comprises an impedance detector. The present
disclosure includes disclosure of a device, wherein the impedance
detector is configured to obtain first impedance data within the
lumen and second impedance data within the wall of the artery,
wherein the first impedance data is different from the second
impedance data. The present disclosure includes disclosure of a
device, wherein the first element comprises a magnetic element.
The present disclosure includes disclosure of a device, forming
part of a system, the system further comprising a second elongated
body; and a second element positioned at or near the distal end of
the second elongated body. The present disclosure includes
disclosure of a device, wherein the first element is magnetically
attracted to the second element. The present disclosure includes
disclosure of a device, wherein the system further comprises a
balloon catheter configured for advancement over at least part of
the first elongated body. The present disclosure includes
disclosure of a device, wherein a balloon of the balloon catheter
is configured for inflation within the bypass lumen so to expand
the bypass lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosed embodiments and other features, advantages, and
disclosures contained herein, and the matter of attaining them,
will become apparent and the present disclosure will be better
understood by reference to the following description of various
exemplary embodiments of the present disclosure taken in
conjunction with the accompanying drawings, wherein:
FIG. 1 shows layers of an artery, as referenced herein;
FIG. 2 shows a sectional view of vessel having an effective bypass
lumen defined therein relative to an occlusion, according to at
least one exemplary embodiment of the present disclosure;
FIG. 3A shows a device configured as an impedance device, according
to at least one exemplary embodiment of the present disclosure;
FIG. 3B shows a device having magnetic elements thereon, according
to at least one exemplary embodiment of the present disclosure;
FIG. 4 shows a cut-away view of a vessel having an occlusion
therein and distal ends of devices on either relative side of the
occlusion, according to at least one exemplary embodiment of the
present disclosure;
FIG. 5 shows a cut-away view of a vessel having an occlusion
therein and a distal end of one device advanced into the tunica
intima and advanced between the tunica intima and the tunica media,
according to at least one exemplary embodiment of the present
disclosure;
FIG. 6 shows a cut-away view of a vessel having an occlusion
therein and a distal end of one device advanced into the tunica
intima, advanced between the tunica intima and the tunica media,
and advanced back through the tunica intima on the other side of
the occlusion so that the distal end contacts a distal end of a
second device, according to at least one exemplary embodiment of
the present disclosure;
FIG. 7 shows a cut-away view of a vessel having an occlusion
therein and a balloon catheter advanced over one of the devices
therein, according to at least one exemplary embodiment of the
present disclosure; and
FIG. 8 shows a cut-away view of a vessel having an occlusion
therein whereby a balloon of the balloon catheter is inflated to
open the bypass lumen, according to at least one exemplary
embodiment of the present disclosure
An overview of the features, functions and/or configurations of the
components depicted in the various figures will now be presented.
It should be appreciated that not all of the features of the
components of the figures are necessarily described. Some of these
non-discussed features, such as various couplers, etc., as well as
discussed features are inherent from the figures themselves. Other
non-discussed features may be inherent in component geometry and/or
configuration.
DETAILED DESCRIPTION
For the purposes of promoting an understanding of the principles of
the present disclosure, reference will now be made to the
embodiments illustrated in the drawings, and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of this disclosure is thereby
intended.
The present disclosure includes disclosure of methods, and devices
and systems useful to perform the same, that allow a treating
physician or other interventionalist to sense/identify a general
location of a portion of the device or system within the patient,
such as within an arterial lumen or within the sub-intimal
space.
In at least one embodiment, devices of the present disclosure can
be used to obtain impedance data within an electric field, whereby
said impedance data, or relative changes thereof, can provide the
user of said device with information relating to the specific
location of a distal portion of said devices within a vessel lumen,
within a sub-intimal space, and/or when one device is in physical
contact with another device.
In at least another embodiment, two magnetic portions of said
devices can be used to measure a force and hence determine the
distance between the two well-defined portions, such as cylinders
or other known lengths, such as the known length of the tip of the
device.
As referenced above, CTOs relate to situations where a vessel, such
as an artery, is completely blocked, due to calcification,
thrombus, or other blockage. Traditional balloon angioplasty
procedures can therefore not be performed because, for example, a
wire cannot successfully pierce the blockage to permit a balloon
catheter to operate therethrough.
One known technique to overcome this problem is a subintimal
technique, whereby a distal end of a wire advanced into a vessel
lumen, pushed sub-intimally (below the intima), advanced past the
location of the blockage within the vessel, and then pushed back
into the lumen on the other side of the blockage. A balloon
catheter can then be advanced over the wire, and the balloon can be
inflated/expanded within the sub-intimal space, at the location of
the blockage, to effectively create a new lumen that connects the
lumen of the vessel distal and proximal to the blockage.
FIG. 1 shows a cut-away portion of an artery 100 (an exemplary
vessel of the present disclosure) so that the various tissue layers
can be readily identified. Starting from the outside working in,
the outermost layer comprises the tunica adventitia 102 (also
referred to herein as the adventitia, the tunica externa, or the
externa), the next innermost layer comprises the tunica media 104
(also referred to herein as the media), the next innermost layer
comprises the tunica intima 106 (also referred to herein as the
intima), which itself surrounds a base membrane 108 that surrounds
the overall vessel lumen 110. The intima is generally between 0.5
mm and 1.0 mm thick for most arteries.
In practice, a guidewire is advanced into the arterial wall itself
and into the subintimal space, such as between the intima 106 and
the media 104, to generate the effective new lumen, bypassing the
occlusion, as referenced above when performing such a CTO bypass
procedure. Blood flow can then be restored from the original lumen,
through the false/bypass lumen created using the procedure, and
back into the original lumen on the other side of the occlusion,
such as shown in FIG. 2. As shown therein, a portion of an arterial
wall is effectively opened, adjacent to an occlusion 200, so to
form a bypass lumen 202, effectively reconnecting the original
lumen 110 on both sides of occlusion 200.
Such a procedure has been proven successful to treat CTOs in
certain patients, but as noted above, the procedure itself has
several pitfalls that are now addressed by way of the present
disclosure. In particular, the treating physician or
interventionalist generally does not know with any degree of
certainty where, for example, the tip of the guidewire is located
relative to the occlusion, and therefore generally are required to
break certain rules of interventional practice in order to treat
CTOs. Such a process introduces significant risk, such as risk of
arterial rupture, improper balloon inflation location, and the
like.
The present disclosure includes disclosure of use of an impedance
device, such as a unipolar wire, within the procedure to treat
CTOs. Such an exemplary device is shown in FIG. 3A. Other exemplary
devices may be as shown or described within any of FIGS. 1A-1F
and/or FIGS. 13A-13C of U.S. patent application Ser. No. 14/215,012
of Kassab, filed Mar. 16, 2014 and issued as U.S. Pat. No.
9,462,960 on Oct. 11, 2016, which is incorporated by reference in
its entirety herein, so long as said devices are configured and
operable as referenced herein.
Impedance device 300, as shown in FIG. 3A, comprises an elongated
body 302 configured as wire or a catheter, and comprises an
impedance detector 304 thereon, whereby impedance detector
comprises one or more excitation electrodes 306, 308 and one or
more detection electrodes 310, 312. In at least some embodiments of
devices 300 of the present disclosure, devices 300 comprises two
detection electrodes 310, 312 positioned in between two excitation
electrodes 306, 308, as shown in FIG. 3A. Detector 304 would be
positioned at or near a distal tip 350 of device 300, in various
embodiments. In at least one embodiment of a unipolar device 300 of
the present disclosure, the device 300 comprises one of electrodes
306, 308, 310, 312, and configured to obtain various conductance
measurements using impedance within the vessel 100.
An additional approach of the present disclosure is to use a wire
(an exemplary device 300) having a tip that is magnetic or
ferromagnetic, for example. Such a device 300 could be used with a
medical GPS or other detection system, for example, to track the
magnetic or ferromagnetic tip of the device 300 within the
bloodstream, and to, for example, detect a magnetic or
ferromagnetic force between the tips of two devices 300 being
advanced toward one another. FIG. 3B shows such an exemplary device
300, having a magnetic element 330 at a distal tip 350 of said
device 300. Devices 300 of the present disclosure can have an
impedance detector 304 and/or a magnetic element 330, depending on
desired configuration. Magnetic elements 330 may be configured as
cylinders in various embodiments. Devices 300 can comprise a
detector 304 and a magnetic element 330, as may be desired.
In at least one embodiment, two devices 300 are used, each having
an electromagnetic tip (an exemplary magnetic element 330 at distal
tip 350). A low level electrical charge can be passed through the
magnetic material at the tip of the device to make it
electromagnetic. Once the two devices 300 approach one another with
the electric current turned on, the two tips of the two devices 300
would magnetically connect to one another, and turning off the
electric current would allow the two devices 300 to disconnect from
one another.
FIG. 4 shows a cross-section of a vessel 100, similar to as shown
in FIG. 2, but whereby the bypass lumen 202 has not yet been
formed. Vessel 100, such as an artery, comprises a vessel wall 101.
Procedurally, a first wire (first device 300) is advanced through a
vessel on a first side of the occlusion 200, either in an antegrade
or a retrograde direction. A second device 300 is advanced through
vessel 100 on the other side of the occlusion 200, in the other of
an antegrade or retrograde direction. FIG. 4 shows distal ends 350
of each device 300 positioned on opposite sides of occlusion 200.
Said devices 300 could be advanced through lumen 110 of vessel
until they contact occlusion 200, for example, and withdrawn
somewhat (if desired) so to continue with the procedure referenced
herein. If the devices 300 have magnetic elements 330, the closer
they get to one another, the larger the magnetic attraction force
becomes with respect to the two devices.
FIG. 5 shows the first wire (device 300) entering the vessel at the
tunica intima 106 and advanced to a location between the tunica
intima 106 and the tunica media 104 (or somewhere within the
subintimal space), where it is advanced between the tunica intima
106 and the tunica media 104 (or elsewhere within the subintimal
space) until the distal tip 350 of the device 300 is at or
relatively past the occlusion 200. Device 300 can be further
advanced back through the tunica intima 106 so that the distal tip
350 of the device 300 being advanced between the tunica intima 106
and the tunica media 104 is now present within the lumen 100 again
so to approach, and even contact, the distal tip 350 of the other
device 300 within the lumen.
By way of identifying relative locations of magnetic elements 330
of the two devices 300, such a procedure can be performed so to
generate a bypass lumen 202 that can be subsequently enlarged via
balloon expansion, as referenced in further detail herein. Use of a
detection system 375, shown in block format in FIG. 6, positioned
relative to and/or coupled to one or more of devices 300, can be
used to identify relative locations of magnetic elements 330 of the
two devices 300, such as visually, magnetically, or
electromagnetically. For example, magnetic elements 330 (or other
elements detectable using detection system 375) can be visually
detected through the patient, or in the case of using magnetic
elements 330 that are not electromagnetic, said magnetic elements
330 would be magnetically attracted to one another. Use of
electromagnetic elements (exemplary magnetic elements 330) would
increase said attraction, and measurements of the attraction of the
two electromagnetic elements 330, or one magnetic element 330 or
other metallic element and one electromagnetic element 330,
identified using detection system 375, would identify an increased
attraction as the two magnetic elements 330 approach and even
contact one another. Distances between the two magnetic elements
330 can be known in view of the foregoing and in part based upon a
known length of the two magnetic elements 330 and/or the known
lengths of the devices 300 themselves.
Use of devices 300 having an impedance detector 304 thereon would
follow a similar procedure as described in FIGS. 4-6 and above, but
instead of magnetic attraction, the impedance detectors 304 would
identify changes in impedance indicative of, related to, or between
any number of the following: presence of blood, contacting the
occlusion 200, contacting vessel 100, contacting the tunica intima
106, contacting the tunica media 104, re-entry into lumen 110, and
contacting another device 300. Those changes in
impedance/conductance would provide the information to an
interventionalist performing the procedure relating to where the
impedance detector(s) 304 are during the process. System 375 (such
as a console) coupled to one or more of devices 300 would provide
the impedance/conductance data to the interventionalist. So to
provide certainty with respect to the procedure, for example, the
interventionalist would obtain various conductance measurements
using impedance detector 304 of device 300 within the lumen 110 of
the artery (vessel 100), which would be relatively steady
measurements as being indicative of blood. Should the impedance
detector 304 contact a wall of the vessel 100 or the occlusion 200
itself, the conductance measurements would change, providing such
an indication. The conductance measurements would also change as
the detector 304 contacts, is inserted into, is advanced through,
and exits out of, a wall of vessel 100 itself. When detector 304
contacts a second device 300, the conductance measurements would
change once again. These changes in conductance during the
procedure provide the interventionalist with the information
necessary to ensure that the procedure is being properly performed
to treat the CTO and to effectively create the bypass lumen
202.
Once the procedure has been successfully performed, a balloon
catheter 700, as shown in FIG. 7, can be advanced over device 300
so that a balloon 702 of balloon catheter 700 is positioned within
the bypass lumen 202 adjacent to the occlusion 200. Inflation of
the balloon, as shown in FIG. 8, can cause the bypass lumen 202 to
expand so to be able to handle blood flow therethrough, which can,
for example, move portion of vessel 100 in a direction identified
by the arrows shown in FIG. 8 toward the occlusion. After a desired
amount of time, balloon 702 can be deflated, and balloon catheter
700 can be removed along with devices 300, and the opening within
the vessel 100 (the bypass lumen 202) would be formed therein,
allowing blood to effectively flow past the occlusion 200 through
the bypass lumen 202 (such as shown in FIG. 2), restoring active
blood flow through that portion of the vessel 100 having the
occlusion 200.
In some cases, and as noted above, one device 300 can be delivered
in an antegrade direction through the vessel (such as artery 100).
However, going through the antegrade direction is not always
possible for various reasons, and instead device 300 can be
delivered in a retrograde direction. Should only one direction be
available, one device 300 could be used as described above, to be
advanced into the lumen 110 of the vessel 100 to or near occlusion
200, into the tunica intima 106 to a location between the tunica
intima 106 and the tunica media 104, advanced within the location
between the tunica intima 106 and the tunica media 104 and back
through the tunica intima 106 on the other side of occlusion 200
and into lumen 110 so to generate the bypass lumen 202 as
referenced herein.
At the end of a successful procedure, the two ends of the wires are
cut so to connect the same. Knowing the proximity of the two wires
(distance between relative ends of said wires) and when they touch
one another is valuable information to have with such a
procedure.
In view of the same, the present disclosure includes disclosure of
using two electrical sensing wires that can touch. When said wires
(exemplary devices 300 of the present disclosure) would contact one
another within a vessel, a conductance value (G) obtained by each
wire would spike, providing said valuable information to the
interventionalist. One the two devices 300 contact one another, as
referenced herein, the interventionalist will know the location of
the occlusion 200 and know that advancement of a balloon catheter
700, such as referenced herein, so that the balloon 702 of the
balloon catheter 700 is within the vessel 100 itself so to be
inflated to further open and create an effective bypass lumen
202.
While various embodiments of devices and systems for creating a
bypass lumen in connection with a chronic total occlusion procedure
and methods for performing the same have been described in
considerable detail herein, the embodiments are merely offered as
non-limiting examples of the disclosure described herein. It will
therefore be understood that various changes and modifications may
be made, and equivalents may be substituted for elements thereof,
without departing from the scope of the present disclosure. The
present disclosure is not intended to be exhaustive or limiting
with respect to the content thereof.
Further, in describing representative embodiments, the present
disclosure may have presented a method and/or a process as a
particular sequence of steps. However, to the extent that the
method or process does not rely on the particular order of steps
set forth therein, the method or process should not be limited to
the particular sequence of steps described, as other sequences of
steps may be possible. Therefore, the particular order of the steps
disclosed herein should not be construed as limitations of the
present disclosure. In addition, disclosure directed to a method
and/or process should not be limited to the performance of their
steps in the order written. Such sequences may be varied and still
remain within the scope of the present disclosure.
* * * * *